Notice2026-11760
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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Published
June 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 112 (Thursday, June 11, 2026)</title>
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[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Notices]
[Pages 35486-35488]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11760]
[[Page 35486]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4250]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment,
Maintenance, and Availability of Records; Additional Traceability
Records for Certain Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 13, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0560. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Michael Ellison, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-2093,
<a href="/cdn-cgi/l/email-protection#421210031136232424022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="4b1b190a183f2a2d2d0b2d2f2a65232338652c243d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Establishment, Maintenance, and Availability of Records; Additional
Traceability Records for Certain Foods--21 CFR Part 1, Subparts J and S
OMB Control Number 0910-0560--Reinstatement
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 added section 414 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons
who manufacture, process, pack, hold, receive, distribute, transport,
or import food in the United States establish and maintain records
identifying the immediate previous sources and immediate subsequent
recipients of food. These requirements are codified in the agency's
general enforcement regulations at 21 CFR part 1, subpart J. The FDA
Food Safety Modernization Act (FSMA) signed in 2011, required FDA to
establish additional recordkeeping requirements for facilities that
manufacture, process, pack, or hold foods the Agency designates as
high-risk to facilitate the rapid and effective traceability of such
foods. These requirements are codified in the agency's general
enforcement regulations at 21 CFR part 1, subpart S. Part 1, subpart J
(21 CFR 1.326 through 1.368) sets forth the requirements for
recordkeeping and records access. Part 1, subpart S (21 CFR 1.1300
through 1.1465) provides additional recordkeeping requirements for
persons who manufacture, process, pack, or hold foods FDA has
designated as high-risk in accordance with factors specified by
Congress; we have listed these foods on the Food Traceability List
(FTL) on our website at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list">https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list</a>. The requirement to
establish and maintain records improves our ability to respond to, and
further contain, threats of serious adverse health consequences or
death from contaminated food.
Part 1, Subpart J
Information maintained under these regulations helps us identify
and quickly locate contaminated or potentially contaminated food and
inform the appropriate individuals and food facilities of specific
terrorist threats. Our regulations require that records for non-
transporters include the name and full contact information of sources,
recipients, and transporters; an adequate description of the food,
including the quantity and packaging; and the receipt and shipping
dates (Sec. Sec. 1.337 and 1.345). Required records for transporters
include the names of consignor and consignee, points of origin and
destination, date of shipment, number of packages, description of
freight, route of movement and name of each carrier participating in
the transportation, and transfer points through which shipment moved
(Sec. 1.352). Existing records may be used if they contain all the
required information and are retained for the required time period.
The information collection provisions of Sec. 1.361 are exempt
from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities. The regulations at 5
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records under Sec. 1.361. Accordingly, we have not
included an estimate of burden hours associated with Sec. 1.361.
Part 1, Subpart S
Part 1, subpart S, in accordance with FSMA, establishes additional
recordkeeping requirements for persons who manufacture, process, pack,
or hold foods that the Agency has designated as high-risk foods (i.e.,
placed on the ``Food Traceability List'' (FTL)) in accordance with
section 204(d)(2) of FSMA. Persons are required to maintain records
containing information on critical tracking events in the supply chain
for FTL foods. Part 1, subpart S will help the Agency rapidly and
effectively identify recipients of foods to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious
adverse health consequences or death resulting from foods being
adulterated or misbranded. These additional recordkeeping requirements
strengthen public health protections by documenting the movement of
foods on the FTL throughout the supply chain, enabling FDA to more
rapidly and effectively identify the source of contaminated foods and
aid in the removal of contaminated products from the market. Records
required under this subpart must be maintained for 2 years from the
date they were created or obtained. For more information about
requirements for additional traceability records for certain foods
visit our website at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods</a>, which also includes a guide that
provides key data elements for recordkeeping (<a href="https://www.fda.gov/media/163132/download?attachment">https://www.fda.gov/media/163132/download?attachment</a>).
The information and records required under part 1, subpart S vary
depending on the type of supply chain activities performed with respect
to an FTL food. For harvesting and cooling of foods on the FTL, records
must include
[[Page 35487]]
information about the location for the immediate subsequent recipient,
commodity, quantity, location of farm and harvest area or cooling area,
date of harvest or cooling, and the reference document type and
reference document number (Sec. 1.1325). For the initial packing of a
raw agricultural commodity on the FTL, including sprouts, for each
traceability lot you initially pack, records must include and link the
traceability lot to information about the commodity, date harvested and
received, quantity, location of farm and harvest and/or cooling area,
name and phone number of harvester, and the reference document type and
reference document number (Sec. 1.1330). For the first land-based
receiver of food on the FTL, for each traceability lot obtained from a
fishing vessel, records must include and link the traceability lot to
the traceability lot code assigned, product description, quantity,
harvest date range and locations, location of land-based receiver, date
the food landed, and the reference document type and reference document
number (Sec. 1.1335). For each traceability lot of a food on the FTL
that you ship or receive, records must include and link the
traceability lot to the traceability lot code, product description,
quantity, location description of either the immediate subsequent
recipient or the immediate previous source, location description of
either from which you shipped or for where the food was received, date
the food was shipped or received, location description for the
traceability lot code source, and the reference document type and
reference document number (Sec. Sec. 1.1340 and 1.1345). For each
traceability lot of food that is on the FTL that is transformed,
records must include and link the traceability lot to the traceability
lot code, product description, quantity, date transformed, and the
reference document type and reference document number (Sec. 1.1350).
Part 1, subpart S also requires that persons who manufacture, process,
pack, or hold foods listed on the FTL to maintain records demonstrating
the creation and establishment of a traceability plan (Sec. 1.1315).
A respondent may submit a citizen petition to FDA to request
modified requirements or exemptions from the requirements of subpart S
(Sec. 1.1370). In addition to the requirements of a citizen petition
(21 CFR 10.30), a respondent must: (a) specify the food or type of
entity to which the modified requirements or exemption would apply; (b)
specify the proposed modifications to the requirements; and (c) provide
information demonstrating that the proposed modification or exemption
of the requirements are not necessary to protect the public health.
A respondent may submit to FDA a written request or a citizen
petition to waive one or more requirements (Sec. Sec. 1.1415 and
1.1425). In addition to the requirements for submitting a citizen
petition (Sec. 10.30), a respondent must: (a) specify the type of
entity to which the waiver would apply; (b) provide information
demonstrating why the requirements requested to be waived would result
in an economic hardship for the entity, including information about the
unique circumstances faced by the entity that result in unusual
economic hardship from the application of these requirements; and (c)
why the waiver will not significantly impair FDA's ability to rapidly
and effectively identify recipients of a food to prevent or mitigate a
foodborne illness outbreak or to address credible threats of serious
adverse health consequences or death to humans or animals as a result
of such food being adulterated under section 402 of the FD&C Act or
misbranded under section 403(w) of the FD&C Act; and (d) provide
information demonstrating that the waiver would not otherwise be
contrary to the public interest.
The information collection provision of Sec. 1.1455(c)(3)(ii) is
exempt from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities. The regulations at 5
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records for which there is a requirement to provide
the records in an electronic sortable spreadsheet under Sec.
1.1455(c)(3)(ii). Accordingly, we have not included an estimate of
burden hours associated with Sec. 1.1455(c)(3)(ii).
Description of Respondents: Respondents to this collection of
information are persons that manufacture, process, pack, hold, receive,
distribute, transport, or import food in the United States who are
required to establish, maintain, and provide records, including persons
that engage in both interstate and intrastate commerce.
In accordance with 5 CFR 1320.8(d), we published a 60-day notice
for public comment in the Federal Register of December 9, 2025 (90 FR
57074). One stakeholder provided multiple comments. Although the
commenter generally supported collections of information to support
public safety, there were several comments that questioned the extent
of the number of food facilities creating and maintaining records and
whether the necessity to maintain such records had practical utility.
Another comment offered concern with the cost to comply for smaller
businesses.
As explained earlier in this document, this collection of
information supports regulations in 21 CFR part 1, subparts J and S.
FDA codified the subpart J regulations to support the Bioterrorism Act
(Pub. L. 107-188) and, subsequently, implemented additional
recordkeeping requirements in subpart S for foods we have designated as
high-risk foods in accordance with factors specified by Congress in
FSMA (Pub. L. 111-353). In other words, FDA implemented these
regulations and required this collection of information as directed by
Congress.
These recordkeeping requirements are appropriate and necessary to
protect the public health. These traceability recordkeeping
requirements help FDA rapidly and effectively identify recipients of
certain foods to prevent or mitigate a foodborne illness outbreak and
address threats of serious adverse health consequences or death as a
result of such foods being adulterated under the FD&C Act. The
requirements will reduce the harm to public health caused by foodborne
illness outbreaks and limit adverse impacts on industry sectors
affected by these outbreaks by improving the ability to quickly and
efficiently trace the movement through the supply chain of foods
identified as causing illness, identify and remove contaminated foods
from the marketplace, and develop mitigation strategies to prevent
future contamination. If all facilities did not create and maintain
records, there would be instances that FDA would not be able to quickly
and effectively identify recipients of contaminated food. That could
result in additional serious adverse health consequences or death. It
could also adversely impact the food industry by not being able to
identify specific lot numbers or batches of product in question,
resulting in overly broad recall requests that affect entire segments
of the industry. The recordkeeping requirements of these regulations
are mandated by section 414 of the FD&C Act, and there is no statutory
exception for small businesses. However, in the promulgating
regulations to implement the statutory
[[Page 35488]]
requirements, FDA provides relief for small businesses in the form of
exemptions and partial exemptions set forth in Sec. Sec. 1.327 and
1.1305. FDA also help small businesses comply with our requirements
through our Regional Small Business Representatives and via the
agency's website at <a href="https://www.fda.gov/industry/small-business-assistance">https://www.fda.gov/industry/small-business-assistance</a>. The regulations also allow for requests to modify or exempt
requirements and for waivers.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Requests for modified 5 1 5 10 50
requirements and exemptions;
1.1370.........................
Requests for waivers; 1.1415 15 1 15 10 150
through 1.1425.................
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Total....................... .............. .............. 20 .............. 200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Records maintenance; 1.337, 1.345, and 1.352. 379,493 1 379,493 7........................................ 2,656,451
Create and establish traceability plan; 212,368 1 212,368 8........................................ 1,698,944
1.1315.
Records for harvesting or cooling; 1.1325.... 9,570 575 5,502,750 0.07 (4 minutes)......................... 385,193
Records for initial packer; 1.1330........... 4,313 865 3,730,745 0.07 (4 minutes)......................... 261,152
Records for first land-based receiver;1.1335. 367 1,471 539,857 0.03 (2 minutes)......................... 16,196
Records for shipper and receiver; 1.1340 and 502,000 5,900 2,961,800,000 0.006 (20 seconds)....................... 17,770,800
1.1345.
Transformer; 1.1350.......................... 8,574 1,101 9,439,974 0.03 (2 minutes)......................... 283,199
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Total.................................... .............. .............. 2,981,605,187 ......................................... 23,071,935
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The revised estimated annual burden reflects updates to the
consideration of burden. We believe that the burden for part 1, subpart
J was inadvertently omitted from the previous approval, so we are
adding it here. However, we believe some of the considerations for
burden should have been incorporated with PRA activities instead of
being considered independently. Lastly, considerations of burden for
Sec. Sec. 1.1465(a) and 1.1455(c)(3)(ii) do not apply to the PRA so we
have removed this burden. Section 1.1465(a) is a general solicitation
for comment, which is not considered ``information'' under the PRA
regulations (5 CFR 1320.3(h)(4)). Activities under Sec.
1.1455(c)(3)(ii) applies to an investigation, audit, or action after a
case file is opened for a specific party, which is exempt from OMB
review as discussed earlier in this document (5 CFR 1320.4(a)(2)).
Our estimated burden for the information collection reflects an
overall increase of 4,227,299 hours but a corresponding decrease of
4,973,420 records. We attribute the increase in hours to the return of
burden for part 1, subpart J along with adjustments to the average
burden per recordkeeping. We attribute the decrease in records due to
the reconsideration of activities such as learning new requirements and
training staff and incorporating the time for these activities as part
of the actual information collection.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11760 Filed 6-10-26; 8:45 am]
BILLING CODE 4164-01-P
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